MAUDE Adverse Event Report: EUFLEXXA; HYALURONIC ACID

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Diarrhea (1811); Fainting (1847); Low Blood Pressure/ Hypotension (1914); Nausea (1970); Pain (1994); Concussion (2192); Urinary Frequency (2275); Polydipsia (2604)

Event Date 05/17/2017

Event Type  Injury  

Event Description

First time getting injection.Had injection in both knees on (b)(6) 2016 in the afternoon.Had some pain and pressure in right knee but not the other.Felt okay after walking, followed instructions of not lifting any weight, taking it easy, walking, did not stand for more than 1 hour according to instructions; 8 or 9 at night started urinating until 3am in the morning, every 20 minutes.I do not have diabetes and i was drinking water throughout the night to replenish.Then got nauseous, which lead to diarrhea.Felt so sick, tried to get up to go to couch to lay down and then fainted because low blood pressure.Hit my head and i got a concussion and now i have stitches behind my ear.

• Brand Name: EUFLEXXA
• Type of Device: HYALURONIC ACID
• MDR Report Key: 6647190
• MDR Text Key: 77860795
• Report Number: MW5070463
• Device Sequence Number: 1
• Product Code: MOZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 58 YR
• Patient Weight: 75